CAT.one in vitro manipulation and extraction studies
API ASSAY QUALIFICATION / VALIDATION
Using state of the art instruments, DRUGSCAN conducts robust assay validation designed to provide confidence in the analysis of active pharmaceutical ingredients (API) recoveries in all downstream CAT.one experiments.
The first step for a drug abuser is to manipulate a dosage form using various tools such as grinders, hammers, knives, etc. This is to reduce the tablet or capsule into a form that can be used via sniffing, injection, dose dumping with alcohol, smoking or purification of the API. DRUGSCAN scientists incorporate techniques from both novice and experienced abusers.
LARGE VOLUME EXTRACTION
Abusers will use readily available solvents to extract the API from the matrix materials. DRUGSCAN uses a variety of organic and inorganic solvents as well as various conditions and pretreatment methods to assess the resistance to extraction techniques.
Extracting the API in small volumes of solvents suitable for injection is a common and dangerous method of abuse. CAT.one studies assess the ability to draw into and expel out of syringes with various needle gauges. Scientists also determine the API content in the drawn volume and measure the viscosity down to <1ml.
Heating a drug product to release and inhale the API is another common method of abuse. Using a proprietary apparatus that simulates smoking which was developed and validated by DRUGSCAN and Pinney Associates, our scientists are able to assess the amount of API released after heating and vaporization.
ISOLATION AND PURIFICATION OF API
Sophisticated abusers will use advanced methods to isolate and purify the API after extraction. Our scientists use these same techniques to assess the difficulty and success of using these methods.
DATA AND REPORTS
DRUGSCAN understands that comprehensive and precise reporting is essential for a successful CAT.one study. We provide you with a complete dataset and quality-assured (QA’d) report. The report will include a detailed description of analytical methods used along with observations and conclusions from each study conducted. The data we provide can be used and has been acceptable to the FDA for regulatory filings.